Senior Manager / Associate Director, Manufacturing Job at Beam Therapeutics (Durham, NC)

Senior Director, Manufacturing Engineering

The visionary and results-driven Senior Director of Manufacturing Engineering wi...

Location

United States , Mobile

Salary:

Not provided

Airbus

Expiration Date

Until further notice

Requirements

Bachelor/ Master Degrees Engineering, Mechanical Engineering, or Electrical Engineering or an equivalent combination of education and experience
10+ years in Aerospace Manufacturing Engineering or equivalent Engineering environment
5+ years in senior leadership
Strong leadership skills with the ability to maximize resources and deliver goals
Has a structured way of working and the ability to deal with a volume of complex information
Have the ability to establish and maintain a good relationship with all internal customers
Have the ability to work in an international team
Must possess excellent communication and presentation skills, both verbal and written - including the ability to discuss with Executive Levels in a major company
Must be able to present clear and concise briefings and reports to customers and executives
20% Domestic and International Travel

Job Responsibility

Develop and execute a multi-year manufacturing engineering roadmap that aligns with corporate growth objectives and technological advancements (Industry 4.0)
Develop an Industrial Improvement Roadmap which adapts the Industrial setup to remain compliant, competitive and up to date based on the current Lean methodologies
Develop and deploy a Line Side support for Operations Teams which provides immediate support to resolve complex Manufacturing Engineering points
Lead the execution of A320 build Head of Versions and Variants from Design to Manufacturing and Assembly, ensuring new product introductions (HoV) transition seamlessly into the Manufacturing and Operational areas
Ensure at all times that the Manufacturing Dossiers (means and methods) are matching the Design Drawing sets and that there are no deltas (gaps) to the defined design solution for a given product or buid
Implement and sustain Lean Manufacturing, Six Sigma, and Total Quality Management (TQM) principles to reduce waste, cycle times, and Cost of Non-Quality
Implement and Sustain a system of Quality Management standards which ensure that constant product improvements are realized through Advanced Product Quality Process (PFMEA, PPV, FAI)
Drive the implementation and maturity of the Airbus Operating System, emphasizing the standardization of line balancing and operating instructions
Oversee the deployment of the CAPEX budget for the Industrial System, prioritizing investments in Quality, manufacturing improvements, and efficiency
Manage the definition of the Industrial system and its associated roadmap for short/medium/long term improvements and adaptations based on the defined targets (Quality, Lead Time, Competitiveness)

What we offer

Competitive base salary, incentive compensation which may include profit sharing schemes, retirement savings plan and the ability to participate in an Employee Stock Ownership Plan (“ESOP”)
Paid time off including personal time, holidays and a generous paid parental leave program
Comprehensive insurance coverage including medical (traditional and high-deductible health plans), prescription, dental, vision, life, disability, Employee Assistance Plan (“EAP”) and other supplemental benefit coverances
Upskilling and development opportunities through our global Leadership University, including unlimited access to 10,000+ e-learning courses focusing on ways to develop your employability, certifications, career path as well as the opportunity to participate in accelerated development programmes and both national and international mobility
relocation assistance for qualified positions

Fulltime

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Associate Director, R&D Product Development, Wellbeing Collective

The Americas & EU Technical Leader, Wellbeing International R&D is responsible f...

Location

United States , Trumbull

Salary:

146200.00 - 219400.00 USD / Year

Unilever

Expiration Date

Until further notice

Requirements

Strong R&D TPL experience (senior-level)
Deep expertise in gummy formulation
Based in China with Mandarin fluency to speak to the manufacturers in China
Experience working on TPL projects beyond China, ideally with a regional or global lens
Bachelor's degree required in science or engineering
BS with 12+ years, Masters with 10+ years, or PhD with 7+ years’ experience in formulation development or technology development of which at least 3 years as Technical Project Lead
Excellent understanding of Product development Principles – formulation development for consumer-friendly ingestible dosage forms such as Powders, Gummies/capsules, material understanding, product scale up, product costing, ingredient sources and GMP
Experience working with cross functional teams across geographies
Ability to lead more complex portfolio of innovation/quality & Value Improvement Project (VIP) projects including multiple brands/regions/technologies
Technical leadership by exhibiting and fostering initiative, motivation, judgment, flexibility, and breadth

Job Responsibility

Drive best-in-class product development to support growth ambitions of the Wellbeing Collective international business
Lead innovation and new market entry across Canada, Latin America, the UK, and Europe for WBC brands
Own end-to-end technical delivery for innovation and market expansion
Partner closely with cross-functional teams (Marketing, Supply Chain, Procurement, SERs, Nutrition Science, Quality, and Regulatory) to deliver projects on time and in compliance
Build and deliver a robust innovation pipeline in partnership with the global marketing team
Drive cost savings and strategic business continuity initiatives
Lead and develop a team of formulators and process engineers
Lead end-to-end product development and commercialization
Design cost-effective, sensorially superior, and scalable formulations
Own technical delivery on project teams

What we offer

Health insurance (including prescription drug, dental, and vision coverage)
Retirement savings benefits
Life insurance and disability benefits
Parental leave
Sick leave
Paid vacation and holidays
Access to numerous voluntary benefits
Bonus eligible
Long-Term Incentive (LTI) eligible

Fulltime

Associate Director, Programmes - Space

We are seeking an experienced and highly motivated Programme Manager to lead the...

Location

Germany , Munich; Berlin

Salary:

Not provided

Helsing

Expiration Date

Until further notice

Requirements

Proven experience in programme or project management within the space industry, with a preference for experience with satellite systems and constellations
Demonstrated success in managing complex, multidisciplinary projects from concept to delivery, including the ability to manage budgets, schedules, and risks of large scale space projects effectively
In-depth knowledge of satellite development lifecycles, including design, manufacturing, testing, launch, and operations
Expertise in programme management methodologies, tools (e.g., Jira, MS Project), and best practices
formal management certificate considered a plus
Exceptional leadership, communication, interpersonal, and problem-solving skills
Team-player
Must be eligible for and willing to undergo clearance process for a German "Ü2" Personal Security Clearance

Job Responsibility

Provide overall direction and management for the SAR satellite constellation, ensuring alignment with the company's strategic objectives and stakeholder requirements
Coordinate and lead multidisciplinary teams from different partner companies (payload, bus, software, as well as launch, ground and operations segments) to achieve programme milestones
Ensure the successful integration and testing of the satellites and the overall constellation, providing technical guidance and decision-making
Develop, maintain, and control integrated master schedules, cost baselines, and resource allocation to ensure the programme is delivered on time and within budget
Proactively identify, assess, and mitigate programme risks and opportunities, developing contingency plans as needed
Serve as the primary interface with internal leadership, external partners, customers, and government stakeholders, managing expectations and fostering strong relationships
Provide regular, clear, and concise status updates, reports, and presentations to senior management, customers, and stakeholders on programme progress, issues, and accomplishments
Oversee contract execution, manage supplier relationships, and ensure compliance with all relevant regulations and standards

What we offer

Competitive salary and VSOP options
Occupational Pension and Disability Insurance
Relocation support: up to €2,500 and 4 weeks temporary accommodation
Learning: €500 yearly allowance
Health & wellness: gym membership, mental health support (Nilo.health) and cycle scheme
Social: regularly company events and monthly social allowances
Enhanced parental leave: 22 weeks fully paid for primary caregivers & 6 weeks for secondary caregivers
Family support: 5 days of paid family emergency leave, remote work option during pregnancy and phased return to work at full pay

Fulltime

Associate Director Quality Assurance

Responsible for providing oversight and leadership for Quality on-the-floor and ...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and/or 8 years of directly related experience AND Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance
10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
Direct experience with bulk manufacturing of biopharmaceuticals preferred
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
Your selection for this role will be subject to fulfilling the medical requirements of this job scope

Job Responsibility

Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
Support routine GMP Oversight activities (e.g. SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics
Ensure required Quality resources are available to support commercial operations
Inspection Readiness and Support
Participate in root cause investigations for complex and significant exceptions or issues, leveraging various root cause analysis tools
Support site/network driven QA continuous improvement initiatives/activities
Escalate significant quality issues to Quality Management in a timely manner
Act as delegate to Quality Assurance Director when required to support business needs
Support Drug Substance Alignment Meetings for Functional areas
Providing guidance to the team

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality
Manages the Quality organization in a mid to large size plant
Manages the batch review and release activities
Fulfills the role of PRRC
Directs large programs and departments in support of division or company-wide initiatives
Develops and deploys the quality systems
Understands and deploys processes to assure conformance to regulations
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
Ensuring Post-Market Surveillance (PMS) obligations are met
Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Director HR Operations

KeHE has an immediate opportunity for a strategic Human Resources leader to join...

Location

United States , Hialeah

Salary:

130300.00 - 191070.00 USD / Year

KeHE Distributors

Expiration Date

Until further notice

Requirements

Seasoned HR leader with the ability to proactively contribute HR and business strategies that drive successful outcomes
Ability to flex leadership and communication style to effectively support local, regional, and national partners
Demonstrated judgment in resolving complex and emotional issues consistent with company policies, standards, applicable regulations, and company culture
Proven ability to manage multiple priorities and initiatives under tight time constraints
Strong verbal and written communication skills with the ability to tailor messaging to audience and circumstance
Proven ability to develop, nurture, and maintain trusted advisor relationships with senior leaders
Ability to work successfully under pressure while handling highly sensitive matters
Minimum 15 years of HR business partner experience, including at least 5 years at the Director level leading teams across multiple locations
Distribution, manufacturing, or related operational environment experience strongly preferred
Bachelor’s degree in Human Resources, Business, or a related field or equivalent experience

Job Responsibility

Lead and develop a team of HR professionals to care for employees, protect our culture, and proactively partner with the business to drive strategy and foster growth
Serve as a trusted HR advisor to senior business leaders, proactively anticipating business needs and aligning people strategies to support business goals
Balance driving strategic site and network initiatives while rolling up sleeves to provide tactical HR support as business needs require
Learn the business deeply and adapt people strategies to meet the unique needs of each Distribution Center based on location-specific goals, challenges, and labor market conditions
Partner with operations leadership at local, regional, and national levels to continuously improve employee experience and engagement
Champion change management initiatives in support of continuous improvement, building compelling business cases to influence stakeholders and drive sustainable results
Provide oversight and escalation for day-to-day HR operations, ensuring barriers are removed and business needs are met
Lead complex and sensitive employee relations matters with a high degree of confidentiality and sound judgment
Build strong partnerships across HR functions including Talent Acquisition, Talent Development, Compensation & Benefits, and Compliance
Advise and influence decisions on complex people, process, and culture challenges, offering courageous and balanced people perspectives

What we offer

Benefits on Day 1
Health/Rx
Dental
Vision
Flexible and health spending accounts (FSA/HSA)
Supplemental life insurance
401(k)
Paid time off
Paid sick time
Short term & long term disability coverage (STD/LTD)

Fulltime

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Senior Manager / Associate Director, Manufacturing

Job Description

Job Responsibility

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